Predicting Acute Compartment Syndrome (PACS)

NCT01561261 | Completed DMC

• 1 other identifier: 00004105
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 7

Brief Summary

The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS). The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring). Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data:

• A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels).
• Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).

Conditions

Acute Compartment Syndrome

Keywords

fasciotomy; ACS

Outcome Measures

Primary Outcomes (1)

• Retrospective assessment of the likelihood of compartment syndrome

  Retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data: A physiologic "fingerprint" composed of continuous pressure vs. time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels). Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the SMFA.

  6 months post index injury

Secondary Outcomes (1)

• Clinician agreement in retrospective assessments of the likelihood of ACS.

  6 months post index injury

Interventions

Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP) OTHER

Continuous monitoring of tissue perfusion using NIRS in all 4 leg muscle compartments and IMP via indwelling catheters in anterior and deep posterior compartments. These measures will not provided in real time to treating physicians. All clinical care, including the diagnosis of ACS, will be according to the current standard-of-care practiced at each institution, Clinicians may use the indwelling IMP monitor to obtain up to 2 discrete measures of IMP if they encounter a clinical situation in which they would normally measure IMP as an adjunct in their normal standard-of-care for the monitoring and diagnosis of compartment syndrome. Patients who undergo fasciotomy will also have NIRS and IMP values recorded from all 4 leg compartments immediately before and after fasciotomy.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient between the ages of 18 and 60
• Weight of \> 88 lb/40 kg
• Patient presents with one of the following injuries:
• Closed tibial shaft fracture with displacement, comminution, or segmental pattern
• Closed bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation
• Open tibial shaft fracture (Gustilo Type I, II or IIIA)
• Open bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation (Gustilo Type I, II or IIIA)
• Severe soft tissue crush injury to lower leg
• Gun shot injury to leg
• Proximal fibula fracture
• Injury resulted from a high-energy mechanism (e.g. pedestrian struck; fall \> 10 ft; MVA/MCA at speed \> 30 mph; injury due to shotgun, rifle, or projectile)
• The injury occurs no more than 12 hours prior to initiation of monitoring
• If bilateral leg injuries are present, only the limb that is most severely injured in the judgment of the investigator will be studied
• At least one extremity must be uninjured to serve as a control for muscle oximetry

You may not qualify if:

• Patient may have impending compartment syndrome at time of evaluation; however, the surgeon must be able to initiate monitoring and take at least one set of muscle pressures and obtain one set of tissue oxygenation measurements prior to performing fasciotomy
• Soft tissue wounds that will interfere with monitoring (i.e. the insertion of indwelling pressure catheters and/or application of NIRS pads to the anterior and deep posterior compartments of the leg)
• Patients with known peripheral vascular disease
• Informed consent from the patient or from a legally authorized representative (LAR) is not obtained early enough to begin monitoring within 12 hours post-injury
• Non-ambulatory due to an associated complete spinal cord injury
• Non-ambulatory before the injury due to a pre-existing condition
• Patient speaks neither English nor Spanish
• Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
• Prior extensive traumatic injury requiring surgery to either lower extremity.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (7)

Denver Health and Hospital Authority

Denver, Colorado, 80203, United States

Location

University of Maryland/R Adams Cowley Shock Trauma Medical Center

Baltimore, Maryland, 212101, United States

Location

Hennepin County Medical Center / Regions Hospita

Minneapolis, Minnesota, 55415, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Andrew Schmidt, MD

  Hennepin County Medical Center / UMN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 23, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2017-11

Locations

US (7)